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USP800Track Pharmacy Compliance Program

Hazardous Drug

USP 800 Pharmacy Compliance Program (Hazardous Drug)

What is USP <800>?

The USP <800> Hazardous Drugs – Handling in Healthcare Settings were created by United States Pharmacopeia (USP) to provide a set of practices that would minimize and prevent the potential hazardous drug exposure to personnel, patients, and the greater community. The standards have their most significant impact on Pharmacy Compounders, however, they also have a place in those pharmacies that may be dispensing hazardous drugs only in the final dosage forms that do not require further manipulations before dispensing (typically tablets, capsules, and solutions).

Who requires USP <800> Compliance?

State Boards of Pharmacy
State Labor Departments
Business and Liability Insurances
Accreditation Organizations
Payers
Other Contracting Entities

Additionally, entities like NCPDP are now asking whether your pharmacy is compliant with USP <800>.

What are hazardous drugs?

Drugs are considered Hazardous, according to NIOSH, if they exhibit any of the following:USP795Track provides compliance to the standards for compounding quality nonsterile preparations.

Carcinogenicity
Teratogenicity or developmental toxicity
Reproductive toxicity
Genotoxicity
Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria

There are currently over 220 hazardous drugs on the NIOSH list. While many of these medications are antineoplastic medication, there are some very common medications that your pharmacy probably dispenses every day, including:

carbamazepine
divalproex
estrogens
fluconazole
medroxyprogesterone
paroxetine
phenytoin
tamoxifen
testosterone
warfarin

It's not just for Compounding Pharmacies!

What are hazardous drugs?

The PRS USP800Track Compliance Program is designed to make your Pharmacy Compliant. The program contains all the policies, procedures, forms, and training (based on the regulation and the policies and procedures) to ensure you have the tools to be compliant. The comprehensive USP800Track Program from PRS includes the following:

Customizable Policies and Forms
Personnel Designations
Hazardous Drug Inventory
Customizable Assessment of Risk Templates
Personal Protective Equipment
Engineering Controls
Spills and Cleanup
Reproductive Acknowledgements
Medical Surveillance
Online Documentation of Your Hazardous Drug Inventory
Online Trackable Training For Your Employees

Reach out to our team today to find out more about our USP 800 Program!

Quick Fact:

The main differences between USP 795, USP 797, and USP 800 are in the purposes of each standard:

USP 795

Promote and ensure patient safety in the compounding of non sterile compounded preparations (NSCP).

USP 797

Ensure patient safety in the compounding of sterile compounded preparations (SCP).

USP 800

Protect employees who may be exposed to Hazardous Drugs during their daily routines.

Learn More with PRS Pharmacy Services

View our webinar Understanding the USP <800> Standards in the Community Pharmacy.

Got Questions About Compliance or Credentialing?

Need additional information about this program or any of our Pharmacy Compliance and Credentialing services or products? Our Compliance Specialists are here to help — even if you’re already working with another compliance program. We offer Custom Coverage Gap Plans to fit your needs.

Contact a Compliance Specialist Today and Get the Support Your Pharmacy Deserves!